David Hyman, MD: The FDA has accepted the larotrectinib new drug application, and the PDUFA (Prescription Drug User Fee Act) date, which is the date that they’re obligated to come back with an answer on, is the end of November. We’re hopeful that we’ll see a response sometime before that.

David S. Hong, MD: How would I use this in my own patients? I have a unique population in the sense that I see mostly early drug development patients, so these patients who have NTRK fusions and were first identified with NTRK fusions would be ideal. I think as a community doctor, if a patient does appear to have an NTRK fusion and they are refractory to their standard chemotherapy, this is a great option for those patients. In some cases where patients have no standard chemotherapy, this should be, in my opinion, the first-line therapy in that context.

Alexander Drilon, MD: The hope is that larotrectinib gets approved by the FDA. If it does get approved, of course it underscores the importance of screening solid tumors for these NTRK fusions. I will certainly use larotrectinib in the frontline setting for patients who have stage 4 advanced disease but are treatment naïve. That’s based on the fact that we’re seeing a very high response rate that really beats many standard of care therapies, across the board, for different tumor types.

David Hyman, MD: Use of these inhibitors post approval is really going to be contingent, number one, on identifying patients with TRK fusions. The testing is obviously the first and very critical component. Once we identify a patient that has a TRK fusion, I think the treatment algorithm becomes much more straightforward in that we’re going to be very compelled to use these agents relatively early due to their extremely favorable side effect profile and very striking degree of efficacy.

Transcript Edited for Clarity

Transcript:

David Hyman, MD: The FDA has accepted the larotrectinib new drug application, and the PDUFA (Prescription Drug User Fee Act) date, which is the date that they’re obligated to come back with an answer on, is the end of November. We’re hopeful that we’ll see a response sometime before that.

David S. Hong, MD: How would I use this in my own patients? I have a unique population in the sense that I see mostly early drug development patients, so these patients who have NTRK fusions and were first identified with NTRK fusions would be ideal. I think as a community doctor, if a patient does appear to have an NTRK fusion and they are refractory to their standard chemotherapy, this is a great option for those patients. In some cases where patients have no standard chemotherapy, this should be, in my opinion, the first-line therapy in that context.

Alexander Drilon, MD: The hope is that larotrectinib gets approved by the FDA. If it does get approved, of course it underscores the importance of screening solid tumors for these NTRK fusions. I will certainly use larotrectinib in the frontline setting for patients who have stage 4 advanced disease but are treatment naïve. That’s based on the fact that we’re seeing a very high response rate that really beats many standard of care therapies, across the board, for different tumor types.

David Hyman, MD: Use of these inhibitors post approval is really going to be contingent, number one, on identifying patients with TRK fusions. The testing is obviously the first and very critical component. Once we identify a patient that has a TRK fusion, I think the treatment algorithm becomes much more straightforward in that we’re going to be very compelled to use these agents relatively early due to their extremely favorable side effect profile and very striking degree of efficacy.